Idiopathic Dilation of the BronchiEPITRANSNCT02586883
Bronchial Trans-epithelial Transport in Patients With Idiopathic Multiple Dilations of the Bronchi
A study testing bronchial ddp test in people with Idiopathic Dilation of the Bronchi, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to identify the abnormalities of bronchial trans-epithelial transport of chloride, sodium and bicarbonate in patients with idiopathic dilations of the bronchi. Read more about this study
- Who is it for?
- Ages 2 to 20 years
- Conditions the study is for
- Idiopathic Dilation of the Bronchi
- What is being tested?
- bronchial ddp test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 29 Mar 2016to 23 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Common criteria for all patients
- Age between 2 and 20 years.
- Patient weighing more than 12kg
- Patients with a scheduled bronchoscopy under clinical monitoring (assessment of bronchial involvement, local samples for bacteriological and histological examination)
- Signature of consent by the patient or by the / the holder (s) of parental authority and the investigator
- Patient affiliated to a social security scheme or entitled
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- Patient with contraception (for woman of childbearing age) Specific criteria for idiopathic bronchiectasis patients Patient with idiopathic bronchiectasis in at least two lobes, diagnosis made after extensive screening of known acquired or congenital causes
- Specific criteria for "control" patients without abnormal ion transport
- Patient Not having bronchiectasis s or any supposed alteration in transepithelial ion transport
- Patients with fiberoptic bronchoscopy performed for one of the following indications:
- Pulmonary malformations
- Laryngeal, tracheal, bronchomalacia
- Airway compression
- Interstitial pathology
- Suspicion of foreign body
- Suspected tuberculosis Specific criteria for patients with a typical form of cystic f ibrosis (CF) Patient carrying 2 causing mutations in the CFTR gene (according to CFTR2 database; http://www.cftr2.org/mutations_history.php) and sweat test> 60 milliequivalent per liter (mEq/L).
Who cannot join
- Common criteria for all patients
- Smoking passive or active
- Not essential bronchial endoscopy in the clinical follow
- Extension of bronchoscopy time attributed to the difference in potential bronchial incompatible with the patient's general status
- Patient pregnant or breast feeding
- Hypersensitivity or cons known contraindications to health products for measurement of DDP (isoproterenol, Amiloride, ATP)
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- Specific criteria for idiopathic DDB patients
- Presence of other congenital or acquired etiologies of DDB:
- Typical or atypical cystic fibrosis,
- Immunodeficiency,
- Primary ciliary dyskinesia,
- Abnormal bronchial wall structure (Williams-Campbell syndrome, Mounier-Kuhn, Ehlers-Danlos syndrome, Marfan's disease)
- Infectious DDBs post
- Extrinsic or endobronchial obstruction (foreign body, malformation, middle lobe syndrome)
- Chronic inhalation (GERD, swallowing disorders, gastroesophageal tracheal fistula)
- Allergic bronchopulmonary aspergillosis,
- System disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Bronchial Trans-epithelial Transport in Patients With Idiopathic Multiple Dilations of the Bronchi
The purpose of this study is to identify the abnormalities of bronchial trans-epithelial transport of chloride, sodium and bicarbonate in patients with idiopathic dilations of the bronchi.
Read the detailed description
Dilations of the bronchi happens for one child over 3000. The extended forms may progress to respiratory failure. More than one case over two remains of undetermined cause. If the prototype is the cystic fibrosis, other abnormalities of ionic transport may be the cause of a failure of mucociliary clearance and enhance the idiopathic dilations of the bronchi.
The purpose of this study is to identify the abnormalities of bronchial trans-epithelial transport of chloride, sodium and bicarbonate in patients with idiopathic dilations of the bronchi, in comparison to two others groups of patients (without abnormality of ionic transport/with typical cystic fibrosis).
- Conditions
- Idiopathic Dilation of the Bronchi
- Being tested
- bronchial ddp test
- Keywords
- Dilation of the Bronchi, Bronchial potential difference, Dilation of the Bronchi (DDB)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bronchial ddp testOther
bronchial ddp test during endoscopy, nasal smear, bronchial smear
| Study group | Role | What they receive |
|---|---|---|
| Patients with multiple bronchi dilations | Experimental | Not described Receives: Other: bronchial ddp test |
| Control patients without transport abnormality | Active comparator | Not described Receives: Other: bronchial ddp test |
| Patients with typical cystic fibrosis | Active comparator | Not described Receives: Other: bronchial ddp test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to isoproterenol in solution without chloride ions during bronchial potential difference test (ΔIsoprotérénol / bronchial).
Difference between groups for Level of repolarisation
Measured: up to 5 days
Secondary outcomes (11)
Response to amiloride during bronchial potential difference test
Trans-epithelial transport measured in vivo
Measured: up to 5 days
trans-epithelial ionic transport in the nasal epithelium (nasal DDP)
Trans-epithelial transport measured in vivo
Measured: up to 5 days
trans-epithelial ionic transport of sweat epithelium (sweat test)
Trans-epithelial transport measured in vivo
Measured: up to 5 days
Basal current short circuit
Trans-bronchial epithelial ionic transport evaluated in vitro on bronchial primary cultures
Measured: up to 5 days
Response to Epithelial Sodium Channel (ENaC) inhibitors
Trans-bronchial epithelial ionic transport evaluated in vitro on bronchial primary cultures
Measured: up to 5 days
Activation of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR)
Trans-bronchial epithelial ionic transport evaluated in vitro on bronchial primary cultures
Measured: up to 5 days
Inhibition of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) (inh-172)
Trans-bronchial epithelial ionic transport evaluated in vitro on bronchial primary cultures
Measured: up to 5 days
Activation of Calcium (Ca)-dependent Chloride (Cl-) ion channels
Trans-bronchial epithelial ionic transport evaluated in vitro on bronchial primary cultures
Measured: up to 5 days
Inhibition of Solute Carrier family 26, member 9 (SLC26A9)
Trans-bronchial epithelial ionic transport evaluated in vitro on bronchial primary cultures
Measured: up to 5 days
Response to inhibitors of potassium (K+ ) secretion basolateral
Trans-bronchial epithelial ionic transport evaluated in vitro on bronchial primary cultures
Measured: up to 5 days
Bicarbonate (HCO3- ) secretion in response to forskolin
Trans-bronchial epithelial ionic transport evaluated in vitro on bronchial primary cultures
Measured: up to 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study start29 Mar 2016
- Primary completion23 Nov 2020
- Study completion23 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Dilation of the BronchiStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586883
- Sponsor's protocol ID
- 2015-A00731-48
- Acronym
- EPITRANS
- Status last verified
- Mar 2026
- First submitted
- 13 Jul 2015
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Bronchial Trans-epithelial Transport in Patients With Idiopathic Multiple Dilations of the Bronchi
- ClinicalTrials.gov ID
- NCT02586883
- Acronym / sponsor ID
- EPITRANS / 2015-A00731-48
- Conditions
- Idiopathic Dilation of the Bronchi
- Keywords
- Dilation of the Bronchi, Bronchial potential difference, Dilation of the Bronchi (DDB)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 29 Mar 2016 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 23 Nov 2020 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to identify the abnormalities of bronchial trans-epithelial transport of chloride, sodium and bicarbonate in patients with idiopathic dilations of the bronchi.
Detailed description
Dilations of the bronchi happens for one child over 3000. The extended forms may progress to respiratory failure. More than one case over two remains of undetermined cause. If the prototype is the cystic fibrosis, other abnormalities of ionic transport may be the cause of a failure of mucociliary clearance and enhance the idiopathic dilations of the bronchi.
The purpose of this study is to identify the abnormalities of bronchial trans-epithelial transport of chloride, sodium and bicarbonate in patients with idiopathic dilations of the bronchi, in comparison to two others groups of patients (without abnormality of ionic transport/with typical cystic fibrosis).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with multiple bronchi dilations | Experimental | Other: bronchial ddp test |
| Control patients without transport abnormality | Active comparator | Other: bronchial ddp test |
| Patients with typical cystic fibrosis | Active comparator | Other: bronchial ddp test |
Who may qualify
- Ages
- 2 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (16 listed)
- Common criteria for all patients
- Age between 2 and 20 years.
- Patient weighing more than 12kg
- Patients with a scheduled bronchoscopy under clinical monitoring (assessment of bronchial involvement, local samples for bacteriological and histological examination)
- Signature of consent by the patient or by the / the holder (s) of parental authority and the investigator
Key exclusion criteria (17 listed)
- Common criteria for all patients
- Smoking passive or active
- Not essential bronchial endoscopy in the clinical follow
- Extension of bronchoscopy time attributed to the difference in potential bronchial incompatible with the patient's general status
- Patient pregnant or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| bronchial ddp testbronchial ddp test during endoscopy, nasal smear, bronchial smear | Other | Control patients without transport abnormality, Patients with multiple bronchi dilations, Patients with typical cystic fibrosis |
Primary outcome
Response to isoproterenol in solution without chloride ions during bronchial potential difference test (ΔIsoprotérénol / bronchial).
Time frame: up to 5 days
Difference between groups for Level of repolarisation
11 secondary outcomes
Response to amiloride during bronchial potential difference test
Time frame: up to 5 days
trans-epithelial ionic transport in the nasal epithelium (nasal DDP)
Time frame: up to 5 days
trans-epithelial ionic transport of sweat epithelium (sweat test)
Time frame: up to 5 days
Basal current short circuit
Time frame: up to 5 days
Response to Epithelial Sodium Channel (ENaC) inhibitors
Time frame: up to 5 days
Activation of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR)
Time frame: up to 5 days
Inhibition of Cystic Fibrosis Transmembrane Conductance Regulator (CFTR) (inh-172)
Time frame: up to 5 days
Activation of Calcium (Ca)-dependent Chloride (Cl-) ion channels
Time frame: up to 5 days
Inhibition of Solute Carrier family 26, member 9 (SLC26A9)
Time frame: up to 5 days
Response to inhibitors of potassium (K+ ) secretion basolateral
Time frame: up to 5 days
Bicarbonate (HCO3- ) secretion in response to forskolin
Time frame: up to 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bronchial ddp test in people with Idiopathic Dilation of the Bronchi, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to isoproterenol in solution without chloride ions during bronchial potential difference test (ΔIsoprotérénol / bronchial). (time frame: up to 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.